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Long-term Extension Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01101945
Recruitment Status : Terminated
First Posted : April 12, 2010
Last Update Posted : August 11, 2010
Sponsor:
Information provided by:
Phenomix

Brief Summary:
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: dutogliptin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multi-Center, Long-Term Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202
Study Start Date : July 2007
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: dutogliptin
    400 mg QD


Primary Outcome Measures :
  1. To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments [ Time Frame: 104 weeks ]
  2. To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments [ Time Frame: 208 weeks (U.S. only) ]

Secondary Outcome Measures :
  1. To demonstrate maintenance or lowering of HbA1c and fasting blood glucose [ Time Frame: 104 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
  • Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD

Exclusion Criteria:

  • Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101945


  Show 55 Study Locations
Sponsors and Collaborators
Phenomix

Responsible Party: Hans-Peter Guler, MD, Phenomix Corporation
ClinicalTrials.gov Identifier: NCT01101945     History of Changes
Other Study ID Numbers: PHX1149-PROT202E
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010

Keywords provided by Phenomix:
diabetes
DPP4 inhibitor
dutogliptin
PHX1149

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases